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Monoclonal Antibodies

MEN1611 + Cetuximab for Colorectal Cancer (C-PRECISE-01 Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by Menarini Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
N-K-RAS (exons 2, 3 and 4) and BRAF wild-type and PIK3CA mutated
Must not have
Previous treatment with PI3K inhibitor
Uncontrolled diabetes mellitus (HbA1c > 7%) and fasting plasma glucose > 126 mg/dL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug, MEN1611, to see if it is effective and safe to treat patients with metastatic colorectal cancer.

Who is the study for?
This trial is for adults with metastatic colorectal cancer that has progressed after treatment with certain chemotherapy and anti-EGFR drugs. Participants must have a specific gene mutation (PIK3CA), no prior PI3K inhibitor treatments, stable heart and lung function, controlled diabetes, and no active severe infections or brain metastases.
What is being tested?
The study is testing the combination of MEN1611, a new drug, with Cetuximab in patients whose tumors have a particular genetic change. It's an open-label Phase Ib/II trial which means everyone gets the experimental treatment and researchers track its effectiveness and safety.
What are the potential side effects?
Potential side effects may include reactions to medication infusions, gastrointestinal issues like diarrhea, changes in blood sugar levels or blood pressure, skin reactions due to Cetuximab, fatigue, and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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My cancer is N-K-RAS and BRAF wild-type but has a PIK3CA mutation.
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My cancer returned or worsened after treatment with specific chemotherapy drugs.
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My last cancer treatment with anti-EGFR showed partial improvement or stability for 4+ months.
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My cancer is a type of colon or rectal cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated with a PI3K inhibitor before.
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My diabetes is not under control, with high HbA1c and fasting glucose levels.
Select...
I have a history of HIV or active hepatitis B or C.
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I have a history of serious heart problems that are not under control.
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I have ongoing lung problems that are not under control.
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I have moderate to severe diarrhea.
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I am currently on long-term steroids or other drugs that weaken my immune system.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Best overall response rate (ORR) according to RECIST v.1.1
Determination of recommended phase II dose (RP2D)
Secondary study objectives
Therapeutic procedure

Side effects data

From 2013 Phase 2 trial • 86 Patients • NCT01256385
75%
Fatigue
65%
Anemia
48%
Hyperglycemia
43%
Lymphocyte count decreased
38%
Anorexia
35%
Platelet count decreased
35%
Constipation
35%
Cough
35%
Nausea
30%
Pain
30%
Mucositis oral
28%
Dyspnea
28%
White blood cell decreased
28%
Hypoalbuminemia
25%
Alanine aminotransferase increased
25%
Cholesterol high
25%
Hypertriglyceridemia
23%
Dysphagia
20%
Depression
20%
Fever
20%
Hypophosphatemia
20%
Weight loss
18%
Alkaline phosphatase increased
18%
Insomnia
18%
Non-cardiac chest pain
18%
Aspartate aminotransferase increased
18%
Headache
18%
Hyponatremia
18%
Hypocalcemia
18%
Hypokalemia
15%
Edema face
15%
Vomiting
15%
Creatinine increased
15%
Neck pain
15%
Peripheral sensory neuropathy
13%
Infections and infestations - Other
13%
Diarrhea
13%
Dysgeusia
13%
Rash acneiform
13%
Rash maculo-papular
10%
Neutrophil count decreased
10%
Arthralgia
10%
Dizziness
10%
Edema limbs
8%
Anxiety
8%
Oral dysesthesia
8%
Respiratory failure
8%
Pneumonitis
8%
Pruritus
8%
Facial pain
8%
Back pain
8%
Dry mouth
8%
Dry skin
8%
Hypertension
8%
INR increased
8%
Neck edema
5%
Allergic rhinitis
5%
Pleural effusion
5%
General disorders and administration site conditions - Other
5%
Hypernatremia
5%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
5%
Skin infection
5%
Dyspepsia
5%
Ear pain
5%
Epistaxis
5%
Gastroesophageal reflux disease
5%
Generalized muscle weakness
5%
Hypomagnesemia
5%
Leukocytosis
5%
Lung infection
5%
Lymphedema
5%
Sore throat
5%
Tumor pain
5%
Urinary frequency
5%
Hearing impaired
5%
Sinusitis
5%
Chills
5%
Dehydration
5%
Hypercalcemia
5%
Hyperkalemia
5%
Myalgia
5%
Papulopustular rash
3%
Alopecia
3%
Oral pain
3%
Vertigo
3%
Tracheostomy site bleeding
3%
Pharyngeal hemorrhage
3%
Laryngeal obstruction
3%
Anorectal infection
3%
Hypoxia
3%
Pleural infection
3%
Pleuritic pain
3%
Pneumothorax
3%
Respiratory, thoracic and mediastinal disorders - Other
3%
Stridor
3%
Postnasal drip
3%
Skin and subcutaneous tissue disorders - Other
3%
Skin ulceration
3%
Eye disorders - Other
3%
Heart failure
3%
Tracheal hemorrhage
3%
Blurred vision
3%
Hypotension
3%
Palmar-plantar erythrodysesthesia syndrome
3%
Peripheral motor neuropathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (Temsirolimus)
Arm A (Cetuximab and Temsirolimus)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: MEN1611Experimental Treatment2 Interventions
MEN1611 + Cetuximab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MEN1611
2020
Completed Phase 2
~100
Cetuximab
2011
Completed Phase 3
~2480

Find a Location

Who is running the clinical trial?

Menarini GroupLead Sponsor
43 Previous Clinical Trials
12,575 Total Patients Enrolled
Josep Tabernero, MD PhDStudy ChairVall d' Hebron Institute of Oncology (VHIO), Barcelona, Spain

Media Library

Cetuximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04495621 — Phase 1 & 2
Colorectal Cancer Research Study Groups: MEN1611
Colorectal Cancer Clinical Trial 2023: Cetuximab Highlights & Side Effects. Trial Name: NCT04495621 — Phase 1 & 2
Cetuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04495621 — Phase 1 & 2
~5 spots leftby Dec 2025
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